MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS CMV IGG; CYTOMEGALOVIRUS IMMUNOASSAY

Catalog Number	09118551190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys cmv igg results for 4 patient samples on a cobas e 801 analytical unit.Patient 1: the elecsys cmv igg result was < 0.15 u/ml (non-reactive).On (b)(6) 2024, the cmv igg result using the abbott alinity method was 22.770 ui/ ml (reactive).The avidity was 98.9 %.Patient 2: on (b)(6) 2025, the elecsys cmv igg result was < 0.15 u/ml (non-reactive).The cmv igm result was 0.345 coi (non-reactive).On (b)(6) 2024, the cmv igg result using the abbott alinity method was 14.14 ui/ml (reactive).Patient 3: on (b)(6) 2025, the elecsys cmv igg result was < 0.15 u/ml (non-reactive).On (b)(6) 2025, the cmv igg result using the abbott alinity method was 9.530 ui/ml (reactive).Patient 4: on (b)(6) 2025, the elecsys cmv igg result was < 0.15 u/ml (non-reactive).The cmv igm result was 0.137 coi (non-reactive).On (b)(6) 2025, the cmv igg result using the abbott alinity method was 11.590 ui/ml (reactive).The cmv igm results for all of the patients were negative.
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).The samples were requested for investigation.The investigation is ongoing.
Additional Manufacturer Narrative
D4 expiration date was updated.The calibration and qc were acceptable.The patient samples were investigated.The non-reactive elecsys cmv igg results were reproducible for all samples.Extensive analysis of the patient samples revealed that patient 2 and patient 4 had correct negative results.The non-reactive result for patient 3 is considered a false negative, and the immune status of patient 1 could not be confidently assessed despite extensive analysis.The investigation did not identify a product problem.

• Brand Name: ELECSYS CMV IGG
• Common Device Name: CYTOMEGALOVIRUS IMMUNOASSAY
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21993039
• Report Number: 1823260-2025-01430
• Device Sequence Number: 17209349
• Product Code: LFZ
• UDI-Device Identifier: 07613336198469
• UDI-Public: 07613336198469
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K220911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Catalogue Number: 09118551190
• Device Lot Number: 823186
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/14/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female